C.03.318 (1) Subject to subsection (2), the Minister shall reinstate the authorization if the sponsor provides the Minister with sufficient evidence to establish that the study does not present a risk of injury to the health of study subjects or other persons, within the following periods:
(a) in the case of a suspension under subsection C.03.317(1), 30 days after the day on which the suspension is effective; or
(b) in the case of a suspension under subsection C.03.317(4), the period specified in the notice sent under subsection C.03.317(5).
(2) If the Minister does not reinstate any part of an authorization that was suspended, the Minister shall amend the authorization to remove that part.
- SOR/2012-129, s. 5.
C.03.319. (1) The Minister shall cancel an authorization, in its entirety or in respect of a study site, in either of the following circumstances:
(a) the study is discontinued in its entirety or at that study site by the sponsor under section C.03.316; or
(b) the sponsor fails to provide the Minister with the evidence required by subsection C.03.318(1) within the specified period.
(2) When the Minister cancels all or part of an authorization, she or he shall send the sponsor a notice that sets out the reasons for the cancellation and the effective date.
- SOR/2012-129, s. 5.
Schedule D Drugs
C.04.001. In this Division,
- “date of manufacture”
“date of manufacture” means
(a) in the case of a product for which a standard of potency exists, the date it satisfactorily passes a potency test,
(b) in the case of an animal product for which no standard of potency exists, the date of its removal from the animal, and
(c) in the case of a product other than an animal product for which no standard of potency exists, the date of cessation of growth; (date de fabrication)
“drug” means a drug listed in Schedule D to the Act that is in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule D to the Act; (drogue)
“licence” or “Canadian licence”[Repealed, SOR/97-12, s. 31]
“manufacturer” [Repealed, SOR/97-12, s. 31]
- SOR/97-12, s. 31.
C.04.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division.
- SOR/97-12, s. 32.
- Date modified: